(73 days)
The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
This document, K062842, is a 510(k) summary for the Lorenz Twist Drills. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not, therefore, require a Premarket Approval (PMA).
This document does not contain information regarding detailed acceptance criteria or a study that proves the device meets specific performance criteria beyond substantial equivalence. 510(k) submissions typically focus on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and performance data if relevant, rather than detailed clinical studies with specific performance benchmarks common for novel devices.
Therefore, many of the requested fields cannot be filled from the provided text because such information is not typically included in this type of FDA submission for devices like simple surgical drills.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in 510(k) summary | Not specified in 510(k) summary |
Explanation: The document does not describe specific numerical acceptance criteria (e.g., drill bit sharpness, durability over a certain number of uses, or specific force required for drilling) or quantitative performance data to meet such criteria. The 510(k) process for a device like a twist drill primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that the performance is similar and acceptable based on the predicate's established safety and effectiveness. The materials (Stainless Steel) are mentioned, which is a key characteristic for comparison.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
Explanation: This 510(k) summary does not mention any specific test sets, clinical studies, or data provenance to evaluate the device's performance in a quantitative manner. The evaluation is centered on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described in this 510(k) summary. Surgical drills, particularly those intended for general bone drilling, typically do not require expert-established ground truth in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no described test set requiring one.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual/powered surgical drill, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted earlier, ground truth in the context of expert consensus or pathology is typically for diagnostic devices. For a surgical drill, the "ground truth" of its function would be its ability to drill holes in bone effectively and safely, traditionally assessed through engineering tests and comparison to established predicate devices, rather than a clinical ground truth established by experts in a diagnostic sense.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment for such a set.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).